Safety, tolerability, and immunogenicity of V114 in healthy infants
- Conditions
- Prevention of pneumococcal disease associated with serotypes included in the vaccine.MedDRA version: 20.0Level: PTClassification code 10061353Term: Pneumococcal infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2018-004109-21-Outside-EU/EEA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- Not specified
1. Is healthy (based on a review of medical history and physical examination) based on the clinical judgement of the investigator.
2. Is male or female, approximately 2 months of age, from 42 days to 90 days inclusive, at
the time of obtaining the informed consent.
3. Has a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent. The legally acceptable representative may also provide consent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research.
Are the trial subjects under 18? yes
Number of subjects for this age range: 1720
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Has a history of IPD (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease.
2. Has a known hypersensitivity to any component of the PCV, any component of the licensed pediatric vaccines to be administered concomitantly in the study, or any diphtheria toxoid-containing vaccine.
3. Has any contraindication to the concomitant study vaccines being administered in the study.
4. *Had a recent febrile illness (rectal temperature =38.1°C [=100.5°F] or axillary temperature =37.8°C [=100.0°F]) occurring within 72 hours prior to receipt of study vaccine.
5. Has a known or suspected impairment of immunological function.
6. Has a history of congenital or acquired immunodeficiency.
7. Has or his/her mother has a documented human immunodeficiency virus (HIV) infection.
8. Has or his/her mother has a documented hepatitis B surface antigen – positive test.
9. Has known or history of functional or anatomic asplenia.
10. Has failure to thrive based on the clinical judgement of the investigator.
11. Has a bleeding disorder contraindicating intramuscular vaccination.
12. Has a history of autoimmune disease.
13. Has a known neurologic or cognitive behavioral disorder.
14. Has received a dose of any pneumococcal vaccine prior to study entry.
15. Has received >1 dose of monovalent hepatitis B vaccine or hepatitis B based combination vaccine prior to study entry.
16. Has received a dose of any acellular pertussis- or whole cell pertussis-based combination vaccines, Haemophilus influenzae type b conjugate vaccine, poliovirus vaccine, rotavirus vaccine, or any combination thereof, prior to study entry.
17. *Meets one or more of the following systemic corticosteroid exclusion criteria:
a. Has received systemic corticosteroids (equivalent of =2 mg/kg total daily dose of prednisone or =20 mg/d for persons weighing >10 kg) for =14 consecutive days and has not completed this course of treatment at least 30 days prior to the first dose of study vaccine at randomization.
b. Has received or is expected to receive systemic corticosteroids within 14 days prior to any dose of study vaccine.
c. Is expected to require systemic corticosteroids within 30 days after any study vaccination during conduct of the study.
18. *Has received other licensed non-live vaccines within 14 days before receipt of study vaccines or is scheduled to receive any licensed non-live vaccine within 30 days following receipt of study vaccines.
19. *Has received a licensed live vaccine within 30 days before receipt of study vaccines or is scheduled to receive any live vaccine within 30 days following receipt of study vaccines.
20. Has received a blood transfusion or blood products, including immunoglobulins.
21. Has participated in another clinical study of an investigational product before the beginning or anytime during the duration of the current clinical study.
22. Has any other reason that, in the opinion of the investigator, may interfere with the evaluation required by the study. Reasons may include, but are not limited to, being unable to keep appointments or planning to relocate during the study.
23. Is or has an immediate family member (eg, parent/legal guardian or sibling) who is investigational site or Sponsor staff directly involved with this study.
For items with an asterisk (*), if the participant meets these exclusion criteria, Visit 1
may be rescheduled for a time when these criteria a
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method